Injuryboard Commentary - Medtronic

Medtronic...Beleaguered Consumers and Yet Another Recall

Brenda Fulmer — Tue, 29 Sep 2009 15:31:58 GMT

On August 27, 2009, the Food & Drug Administration issued yet another recall for a device manufactured by Minnesota-based Medtronic (who also has experienced recalls of its pain medication infusion pumps, defibrillators, defibrillator leads, and insulin pumps recently). This Class I recall, the most serious level of recall of an FDA-approved medical device, involved the Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit. These devices are used in connection with the popular Medtronic SynchroMed II and SynchroMed EL infusion pumps; these pumps deliver pain medications such as baclofen and other drugs directly into the spine. Chronic pain patients have been led to believe that implanted pain pumps such as the Medtronic devices would provide a panacea and avoid all of the pitfalls of chronic use of narcotic pain medication, including the stigma and potential addiction associated with such drugs, their side effects, and recent safety concerns (including manufacturing defects in Fentanyl pain patches that leach toxic levels of the drug due to improper sealing techniques and Ethex morphine pills manufactured at double strength).

The latest recall for Medtronic and its pain pump line stems from design defects that prevent the catheter from properly connecting to the infusion pump, which could lead to disconnection of the pump or a blockage. The inability of the device to properly administer a steady stream of pain medications to a patient creates the potential for an inadvertent overdose or unnecessary suffering for the patient who receives an inadequate level of pain medication. The SynchroMed II line of infusion pumps has been in the news a great deal over the past couple of years with numerous advisories of potential safety problems. These are located on the Medtronic site and can be accessed by clicking on "Medical Device Safety Alerts". They include:

July 2009 -- Premature Battery Removal
August 2008 -- Potential Effects of MRI Imaging on Pump Performance
June 2008 -- Potential Disconnection of Sutureless Connector Catheters
May 2008 -- Pump Malfunction Due to Missing Propellant
January 2008 -- Formation of Inflammatory Mass at Catheter Tip Leading to Serious Injuries
August 2007 --Notification of Malfunction of Synchromed El Pump with Stalling Due to Gear Shaft Wear
November 2006 -- Educational Brief to Physicians on proper monitoring of patients to reduce risk of death or serious injury during initiation of intrathecal opioid therapy for pain
July 2006 -- Voluntary Worldwide Medical Device Recall for Model 8731 Intrathecal Catheter and Model 8958 Intrathecal Catheter Distal Revision Kit (due to platinum-iridium tip becoming dislodged by guide wire during implantation)
May 2006 -- Medical Device Recall of Model 8627 SynchroMed EL Due to Pump Reliability Concerns
January 2006 -- Education Brief for Patients regarding drug formulations using preservatives that may be neurotoxic or compromise the safe use of the Medtronic infusion pumps

Patients who have received these devices should contact their physician for more information regarding the impact of these various recalls on the functioning and safety of their implanted infusion pumps. Medtronic has a sales force that regularly calls upon physicians and should be able to provide current safety data to healthcare providers and their patients. There are also tools available on Medtronic’s web site that enable physicians and patients to input the serial number for a particular infusion pump device to determine whether it is impacted by the various safety alerts and recalls.

It appears from the documents published on Medtronic’s web site that it has also enhanced its warranty coverage to include some of the out of pocket expenses incurred by patients. A review of these warranty supplements, however, indicates that patients are only being reimbursed up to $1,000 for out of pocket expenses associated with surgery and medical care necessitated by the defective product and that health insurers are left without recourse for the tens of thousands of dollars that they might be required to pay for medical care necessitated by the litany of defects associated with these pain pumps. This is an excellent example as to why federal preemption for FDA-approved medical devices (as outlined in the Medtronic v. Riegel decision) is a travesty for patients, physicians, and health insurers, all of whom are shouldering the burdens created by poorly designed and manufactured medical devices. It is for this reason that the Medical Device Safety Act, which would once again hold device manufacturers such as Medtronic responsible for their defective products, is gaining significant, bi-partisan support in Congress. More information about federal preemption and how it unfairly shields manufacturers of defective products can be found on our firm’s web site. We urge you to contact members of Congress to voice your support for this very important safety legislation.

Originally posted at InjuryBoard by Brenda Fulmer

Medtronic Recall over Infusion Pump and Catheter

Greg Jones — Wed, 16 Sep 2009 09:55:05 GMT

Medtronic Inc. has issued a statement that a catheter and an infusion pump it produces pose serious health risks when used together. This action and potential risk has caused the U.S. Food and Drug Administration to classify the combination as a Class 1 recall.

The two products – the Sutureless Connector intrathecal catheter and the IsoMed constant-flow infusion pump – are still able to be produced because they only pose risks when used together, according to Medtronic spokeswoman Cindy Resman on Monday.

The product recall is about the SC Catheter and Revision Kit Models 8709SC, 8731SC, 8578, and 8596SC, when paired with the IsoMed Pump Model 8472. The particular IsoMed Pump was discontinued in September 2008 “as part of a planned product phase-out,” according to the company.

A disruption in therapy and revision surgery, putting a patient at risk for serious injury or death, are the potential damages, Medtronic said.

Physical signs can include “a drug or cerebrospinal fluid leakage into surrounding tissue, resulting in tissue damage, loss of or change in therapy, a return of underlying symptoms, drug withdrawal symptoms, a severe (“spinal”) headache, and/or a clinically significant or fatal drug underdose,” Medtronic said.

The company voluntarily sent notification letters to doctors in a process that began in August and is ongoing, it said.

Medtronic said patients should seek medical attention immediately if they experience underlying symptoms or drug withdrawal symptoms.

Originally posted at InjuryBoard by Greg Jones

Congress Has A Chance To Protect Consumers Who Use Medical Products

Mike Bryant — Fri, 28 Aug 2009 09:23:00 GMT

For some time now, members of the Injuryboard have been writing about the major impediment on medical device cases. They have been thrown out of court, because of federal preemption. There are tragic stories of people who are injured by these products who simply have no recourse. It's one of the hardest things to do, when someone calls with a letter that says the product that they have in them is faulty, and they have to be told, sorry you have no protection, despite what the Constitution says about your civil rights.

The question is if Congress should reverse the 2008 US Supreme Court decision of Riegel v. Medtronic, Inc? That ruling granted immunity to medical devices that gain approval from the Food and Drug Administration under the Medical Devices Amendment of 1976. In affect silencing individual state's consumer protections.

Last week, the U S Senate took testimony on the Medical Device Liability Bill:

Two Minnesota families testified concerning their children who died due to problems with Medtronic pacemakers and Medtronic implantable cardiac defibrillators.

Another Medtronic defibrillator user from Iowa testified that he received 22 electric shocks within a span of 53 minutes from a faulty implant . He said, “My hope is that no one else ever has to go through the pain and agony that I experienced with the fractured lead, and that Medtronic is held responsible for the injuries it has caused other patients like me.” He was asked to testify by Senator Tom Harkin (D-IA).

Also testifying were a Texas man who was shocked six times by a faulty pacemaker and a six year-old Illinois girl, who was also shocked by a faulty defibrillator.

William Maisel, MD, director of the Medical Device Safety Institute and a cardiologist who chairs an FDA advisory committee, testified that "the FDA does an 'exceptional job' of monitoring the safety of medical devices." But, he added, "the postmarketing data is an issue." Dr. Maisel "said it is 'simply impossible' for the FDA to continue to monitor the safety of every medical device it has approved."

Hopefully, the senate will listen. The question isn't what these people should get. It is simply that they should have the right to make the claim. Let the system work with each case standing on it's merits.

Originally posted at InjuryBoard by Mike Bryant

Medtronic Paid Surgeon May Have A Different Definition Of Full Disclosure

Mike Bryant — Wed, 26 Aug 2009 20:40:00 GMT

There have been a number of stories about doctors who have been paid big money by Medtronic at the time they were doing studies or prescribing the use of Medtronic products. One of those researchers has been under scrutiny about whether he really did the tests. The reasoning behind the University of Minnesota requirement for their doctors to disclose links to outside companies was to make sure patents get full disclosure.

Despite these changes, a Senate committee is claiming that Dr. David Polly, head surgeon of the University of Minnesota Department of Orthopedic Surgery:

1) Testified before a Senate committee without disclosing that he was being paid by Medtronic.

2) Told Medtronic about the progress of government-sponsored research.

3) May have given inaccurate information to a university ethics committee.

All at the same time that the doctor was receiving $1.2 million in consulting fees, honoraria, and expenses from Fridley-based Medtronic between 2003 and 2007. The response has been that there was proper disclosure, which you would think would be able to be confirmed.

Medtronic needs to continue to disclose their payments to doctors. Hopefully, the investigation of what happened here will continue. It is vital that patients get the right information about the products that are being used.

Originally posted at InjuryBoard by Mike Bryant

When Defibrillators Fail

Mike Ferrara — Fri, 14 Aug 2009 22:33:27 GMT

No one using a heart defibrillator ever wants to experience what Michael Mulvihill of Bettendorf, Iowa did two years ago. All of a sudden, while he was driving on the interstate with his wife in the car, he began to see blue flashing lights in his eyes and his body began to shake. His defibrillator was malfunctioning, sending painful shocks through his body. The device malfunction nearly killed Mulvihill and his wife; the man barely managed to pull the car over in the middle of a construction zone.

A representative from Medtronic confirmed the device had shocked Mulvihill 22 times in 53 minutes. The wire that connects the defibrillator to the heart was recalled four months later after over a hundred reports of the lead malfunctioning had been reported to the Food and Drug Administration (FDA). However, because of a U.S. Supreme Court ruling last year, Mulvihill does not have any recourse to hold the manufacturer accountable.-AAJ

After the malfunction, Mulvill was forced to take an early retirement; his job required too much interstate driving. His family will have to make it on less than they’d planned.

In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that because the Food and Drug Administration (FDA) had approved a medical device through the pre-market approval process, patients injured by medical devices do not have any recourse to hold the manufacturers accountable. The Supreme Court ruled earlier this year in Wyeth v. Levine that patients harmed by prescription drugs can hold manufacturers accountable in state courts, creating a double standard between prescription drugs and medical devices. -AAJ

On August 4, Mulvihill testified about his life-threatening experience before the US Senate Health, Education, Labor, and Pensions Committee, asking Congress to pass the Medical Device Safety Act (MDSA), restoring patients’ right to hold device manufacturers accountable for the harms they cause when their devices malfunction, regardless of FDA approval.

Tragically, Mulvihill’s story is similar to hundreds of other patients who have been harmed by medical devices but have no legal recourse, while the profits of the companies that produce these faulty devices increase every day. Wyeth v. Levine affirmed patients’ rights to seek compensation from drug companies; it’s time for device manufacturers to answer to patients too.

Originally posted at InjuryBoard by Mike Ferrara

Is there something wrong with the Bacolfen Pump, Model No. 863740 causing overdoses in patients?

Steve Lombardi — Tue, 11 Aug 2009 12:03:00 GMT

When we are ill or have a medical condition, we generally trust our doctors and medical system to prescribe us treatments which will help us to feel better. However, sometimes, there are dangers in our treatments which may not be readily apparent.

Is there something quirky about the programming mechanism of the Baclofen Pump or is it just a case of the fat finger syndrome?

The drug Baclofen is used as an antispastic agent and also as a muscle relaxer and is often used to treat people with spinal injuries or multiple sclerosis. For some patients, the drug is administered to the patient via an implanted pump.

This pump is designed and programmed to distribute six months worth of medicine in carefully measured doses. However, there have been instances where patients have been overdosed and under-dosed on the Baclofen through their pumps. Baclofen toxicity is very serious and can potentially be life threatening. Acute under-dosing can also be a serious life-threatening condition. A patient suffering from Baclofen toxicity may experience mild symptoms such as nausea or lightheadedness, but some patients have suffered from respiratory distress and in at least one instance, coma. See Tuanli, Intrathecal Baclofen Toxicity and Deep Coma in Minutes, et al. 2006 American Paraplegia Society and What Are the Advantages of the Bacolfen Pump System? Published on MedicineNet.com.

This toxicity occurs when a patient receives too much Baclofen. A malfunctioning pump can cause this to occur. However, there have also been instances reported where the pump has malfunctioned and has not delivered any medicine at all and patients have suffered from severe withdrawal syndrome Mohammed and Hussain, Intrathecal baclofen withdrawal syndrome- a life-threatening complication of baclofen pump: A case report. 2004, BMC Clin. Pharmocol. This withdrawal syndrome can also be life threatening. Why is this happening? Is there something about the Baclofen pump that is causing it to malfunction or is it simply the result of preventable human error in the doctors and surgeons implanting and programming the pumps? In the instance above the cause was noted to be a programming error.

Case Presentation

"A 24-year-old man with a past medical history of cerebral palsy and spastic quadriparesis developed hyperthermia, disseminated intravascular coagulation, rhabdomyolysis, acute renal failure and multisystem organ failure leading to a full-blown intrathecal baclofen withdrawal syndrome. Intrathecal baclofen pump analysis revealed that it was stopped due to some programming error. He was treated effectively with supportive care, high-dose benzodiazepines and reinstitution of baclofen pump."

The FDA has taken note and has concerns that there may in fact be a fatal flaw in the pump itself. In 2002, the FDA changed its warnings of Baclofen pumps and injections to warn about the risk from the withdrawal syndrome; at that time, the FDA had notice of six deaths which were linked to the pumps’ failure and subsequent withdrawal syndrome of the patient. Lioresal Intrathecal (Baclofen Injection): Overview.

In June of this year as reported by the Wall Street Journal, the FDA sent warning letters to Medtronic, the manufacturer of the pumps which are used for the administration of Baclofen. In the letters, the FDA expressed its concern with what it considered to be a lack of reporting with regard to problems the company knew existed with the pumps; the FDA also was concerned about Medtronic’s response to the reported problems as it took them two years to finally recall the products with the reported problems (http://online.wsj.com/article/SB124585661696447913.html).

"A 24-year-old man was admitted to our intensive care unit (ICU) with a possible diagnosis of seizure disorder and sepsis. He had a past medical history of cerebral palsy and spastic quadriparesis. Three years ago, he had an ITB pump implanted for spasticity refractory to the high doses of oral baclofen. He had a significant improvement in spasticity, social and functional capacity in the past three years. Later, he developed some disorientation and increased spasticity. He was taken to a local physician who prescribed oral baclofen (120 mg daily in four divided doses) for his increased spasticity. He also advised him to have his ITB pump checked immediately. The following day, his spasticity increased even after taking oral baclofen. He developed multiple seizures and respiratory distress in the next 24-hour period. Subsequently, he was admitted in a local hospital where he was orally intubated and transferred to our ICU for aggressive management. ....

Next day, his spasticity improved and an ITB specialist investigated his baclofen pump. His baclofen pump analysis revealed that it was stopped due to some programming error, which was restarted at a previously prescribed baclofen rate (260 μg/day)."

What this seems to show us is that it is not doctors who are to blame in most of the cases of Baclofen pump problems but rather it is the pump itself. In our legal system, a company has a legal duty to ensure that the products it is placing on the market do not suffer from any sort of design or manufacturing flaw or defect and that their warnings about the shortcomings of the products are adequate. The Medtronic pump’s warning label was changed once in 2002 in response to the reports of the withdrawal syndrome but to our knowledge no subsequent warnings have been placed or mandated be placed on the packaging. Doctors are advised that they must constantly and vigilantly monitor any patient that has a pump to ensure its continued functionality and proper dosing.

However, if the problem is with the pump, then it is possible that a consumer who has been injured or suffered as a result of the pump’s malfunction may have a claim in a class action if enough others have been hurt as well. Doctors incorrectly charged with malpractice may also be able to join a class suit. As of yet, there is no class litigation pending but as more people come forward with their stories about malfunctioning Baclofen pumps, litigation may be forthcoming.

"The precise mechanism of action of baclofen as a muscle relaxant and anti-spasticity agent is not fully understood. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal cord level [6], possibly by decreasing excitatory neurotransmitter release from primary afferent terminals, although actions at supraspinal sites may also contribute to its clinical effects. Baclofen also causes enhancement of vagal tone and inhibition of mesolimbic and nigrostriatal dopamine neurons (directly or via inhibiting substance P) [7]. Baclofen is a structural analog of the inhibitory neurotransmitter GABA, and may exert its effects by stimulation of the GABA_Breceptor to cause muscle relaxation. Baclofen reduces increased muscle tone, Babinski sign, tendon reflexes, ankle clonus and sometimes decreases muscle force."

If you or a loved one have been proscribed a Baclofen pump, remain alert. Watch for signs of withdrawal or toxicity which could be warning signs of the pump’s malfunction. Do not be afraid to speak with your doctor if you feel your pump is not working the way it ought. If you or a loved one does begin to experience symptoms of withdrawal or overdose toxicity, get immediate emergency medical treatment and inform the treating emergency room doctor that the patient has a Baclofen pump so that proper procedures can be used. If you or your loved one have been injured or have experienced problems with either withdrawal, toxicity or any other result of a malfunctioning pump, you may have a case against Medtronic. Contact an attorney who specializes in medical malpractice or class action litigation; as with any potential case, always be sure to take notes of what happened and when so that you have a clear record of your experiences. The Lombardi Law Firm has been serving the Iowa community for almost three decades and would welcome a chance to discuss any concerns you may have regarding your malfunctioning pump.

"ITB withdrawal syndrome has been fatal in some cases. Six patients have died out of 27 cases reported to FDA [13]. Most reported episodes of ITB withdrawal were caused by preventable human errors or oversights. However, catheter dislodgement, catheter migration and kinks, and other catheter-related issues might be more common than pump-related malfunctions [1,14]. Close attention to pump refilling and programming procedures may reduce the incidence of ITB withdrawal syndrome."

You are the patient and should not have to worry that the device installed to treat your pain or your symptoms may malfunction and become a risk to your life.

Originally posted at InjuryBoard by Steve Lombardi

Another Medtronic Consultant With a Medtronic Bias

Camryn Hansen — Wed, 29 Jul 2009 22:29:54 GMT

In June, we blogged about an orthopedic surgeon at Walter Reed Army Medical Center who fabricated data and forged researchers’ names in a study to show that the Medtronic bone-growth product Infuse performed “strikingly” better bone grafts than traditional techniques. The surgeon, Dr. Timothy R. Kuklo, was a paid Medtronic consultant.

Now, a Senate investigation, headed by Sen. Charles E. Grassley (R) of Iowa, into the financial ties between doctors and Medtronic has exposed another questionable doctor-company relationship.

Dr. David W. Polly Jr. urged members of a Senate panel in 2006 to continue paying for Defense Department medical research into combat-related injuries. But Dr. Polly did not disclose during his testimony that he was a Medtronic consultant and was billing the company $6,000 for his appearance, according to documents released Tuesday. Instead, he told lawmakers that he was representing a professional medical association of orthopedic surgeons, according to the documents. -New York Times

Dr. Polly, also a University of Minnesota medical professor, actually received some of the Defense Department funds to conduct animal testing on Infuse, the same Medtronic bone growth product Dr. Kuklo fabricated data about. Notably, Dr. Polly was the head of the Walter Reed Army Medical Center orthopedics department until 2003.

Between 2003 and 2007, Dr. Polly received more than $1.14 million in fees and expenses from Medtronic, those records show. (…) In late 2006, university officials allowed him to work on the Defense Department-financed study of Infuse. The medical school knew he was a company consultant, but under the school’s rules Dr. Polly had to acknowledge only that he received more than $10,000 annually. Medtronic paid him about $350,000 that year alone in expenses and fees, the records show. New York Times

Apparently, the University of Minnesota’s medical school ultimately allowed Polly to work on the Defense Department study despite his potential Medtronic bias because the study was looking at rats rather than people, and “because Dr. Polly had said that it was not of economic significance to the company.”

These details confirm that we absolutely must create a more effective, more concrete and universal system governing the way that doctor payments by drug and device companies are reported and taken into account. There needs to be a publicly accessible database disclosing the full and true amounts given yearly to every doctor who consults on the side. Payments to doctors in the form of perks and freebies need to stop altogether. Mandating accountability and transparency now will offset the future costs of fraudulent studies and biased recommendations.

Originally posted at InjuryBoard by Camryn Hansen

Medtronic Recalls Quick-set Infusion Set

Mike Bryant — Wed, 22 Jul 2009 09:31:00 GMT

The first week of July, Medtronic, Inc. (NYSE:MDT) recalled specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. Medtronic recently discovered that approximately two percent of "Lot 8" Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work.

This recall involves Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number "8." The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Visit the Medtronic Diabetes website at www.medtronicdiabetes.com/lot8 to view the labels of "Lot 8" Quick-set infusion sets.

Product problems should be reported to the Diabetes business at Medtronic by calling
800-345-8139 at any time. Adverse reactions or quality problems may also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

If you or a family member is injured by a product, you need to get immediate medical care. If there is a significant affect or injury, you should contact an attorney concerning the problem. Early investigation can include the collection of product, checking recall alerts, and the proper notifying of those who caused the problem.

Originally posted at InjuryBoard by Mike Bryant

800,000 Dollars Paid To One Doctor For What?????

Mike Bryant — Tue, 07 Jul 2009 09:27:00 GMT

This past week, Medtronic confirmed that they paid $800,000 to Timothy Kuklo, an army doctor who consulted on a Medtronic's bone morphogenic protein called Infuse, which induces the formation of bone. The "doctor" is not accused of fabricating those results.

Medtronic spokeswoman Marybeth Thorsgaard said the company put Kuklo on "inactive status" in May after the Army said the study was based on false information, and that Kuklo had forged signatures of purported co-authors of the study.

Kuklo trained doctors and provided educational services to Medtronic starting in 2001. He became a paid consultant in 2006.

She said payments were compensation for Kuklo's work developing products for the company, training doctors and speaking at company events.

Payments were not connected to the study and Medtronic was not involved in any way with the report, Thorsgaard said.

She said none of the data in Kuklo's study was used to win regulatory approval for the Infuse product.

The product has been used as a way to help people with broken bones quickly heal. I've understood it as electric simulation that stimulates the area and leads to a better fusion. But, was Dr. Timothy Kuklo paid to just make this stuff up?

Earlier this year Medronic announced that they would be disclosing their payments to doctors. Hopefully, there will also be an investigation of what happened here. It is vital that patients get the right information about the products that are being used.

Originally posted at InjuryBoard by Mike Bryant

Medtronic Class I Recall of Kappa and Sigma Series Devices

C. Todd Alley — Mon, 22 Jun 2009 12:51:35 GMT

Medtronic, in conjunction with the FDA, has issued Class I recall – the most serious type of recall classification reserved for products whose continued use could lead to serious illness or death - of the following lines of pacemakers:

· Medtronic Kappa Series 600/700/900

· Medtronic Sigma Series 100/200/300

The recall has been issued because of a serious risk of operational failure. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. Pacemaker-dependent patients may experience serious injury or even death. Most of the pacemakers affected by this recall have been implanted in patients for five years or longer.

Alley, Clark & Greiwe has been involved with Medtronic litigation for years, and our attorneys have been directly involved with other Medtronic recalls (including Medtronic Sprint Fidelis Leads and Medtronic Implantable Cardioverter Defibrillators (ICD) devices). While it’s unfortunate that another model line has been recalled, it is not particularly surprising. Please contact our office and we will help you determine if a particular pacemaker is part of this recall.

Originally posted at InjuryBoard by C. Todd Alley